1. Joanna Vivalda Program Official, NIH StrokeNet

2.  Find your application that resulted in the award as an NIH StrokeNet Regional Coordinating Center.  Do you have an individual (larger groups may have 2+) in place to oversee the day-to-day operations across your region? You need a plan now.

3. Communications Plan for your region. Examples:  Quarterly meetings, webinars and/or teleconferences to keep staff engaged & up-to- date.  Weekly/Bi-weekly coordinator calls within your region to review progress & trouble shoot.  Stroke Research Hotline, on-call staff to answer GCP questions.  Coordinate local/regional outreach to support recruitment, as applicable.

4. Operational Management of your region. Examples:  How do you assess feasibility?  How are co-investigators identified & integrated into the network?  Planning for trial placement & allocation of resources.  Will you provide coordinator service or mentoring to your satellites?  Who will oversee training for research personnel at your satellites?  Initiation calls and/or visits with satellites to activate trials; walk through at least 1 phantom enrollment to identify challenges.  Standard research trial orders.  24/7 call across centers for off hours enrollment.  Procedures for data collection and investigational drug/device monitoring (pharmacy, imaging, OR suite, etc.).  Who is responsible for data entry/management; will you provide support to your satellite or will they have qualified staff available?  Who will ship samples, de-identify & transfer images, etc.? Will you staff travel to the satellites or will each need to manage independently?  How will status information flow to your RCC (enrollment, AEs, deviations, etc.).

5. Quality Assurance for your region. Examples:  Coordinate with the NCC & NDMC QA plans.  Review all monitor reports on subjects enrolled at your satellites.  How will you develop corrective action plans & track improvement?  Perform your own monitoring on XX% of cases.

6.  A DRAFT is sent to Judith Spilker for initial feed back.  A final draft is sent to Joanna Vivalda & Judith Spilker.  The approved version will be sent back to the RCC by Joanna.